- Experience Level
We don’t tell our employees what they should care about. They tell us.
At PRA, Philanthropy, charitable giving and social responsibility are more than buzz words for us – they’re ideas we hold up as ideals. Our passion and commitment to improving lives extend far beyond our work and we believe that it is our obligation to empower our employees to find meaningful ways to respond to the needs of others around the world.
You will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s and infectious diseases.
Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.
As Clinical Research Associate, you will be ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle.
Your main duties :
· Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
· Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), Quality Oversight Visits and co-monitoring visits if required
· Conducts co-monitoring visits, if required
· Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
· Assists with investigator/site identification, Ethics Committee submissions, site contract and budget negotiation
· Provides protocol and related study training to assigned sites
· Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
· Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
· Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
· A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
· You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
· Fluent in English plus local language requirements
For more information please visit our website: www.prahs.com
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